Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 55493 

provide (such as name, address, 

telephone number, e-mail address, 

whether you wish to make a 

presentation or participate in the vendor 

display and how to provide FDA with 

a summary of your presentation or 

product). 

You may register to attend the 

meeting at www.fda.gov/cdrh/ocd/udi/ 

index.html. Seating is limited to 300 

persons, and if capacity is reached, 

registration will close. If you register as 

a presenter or to participate in the 

vendor display, you do not need to also 

register as an attendee. 

Because of time constraints, vendors 

may register either to present at the 

meeting or participate in the vendor 

display. You may not register for both. 

If you choose to participate in the 

vendor display, you will have the 

opportunity to share information about 

your products with the FDA and other 

attendees when they visit your display. 

Because of the format of the meeting, 

we will only have a short time for 

additional presentations. We encourage 

attendees to raise their issues and 

concerns during the discussion portion 

of the four main topic areas. We also 

encourage persons and groups having 

similar interests to consolidate their 

information and present it through a 

single representative. By October 16, 

2006, we will schedule each 

presentation and, by e-mail or 

telephone, notify each participant who 

will present of the time allotted to the 

person and the approximate time the 

person’s presentation is scheduled to 

begin. The time allotted for 

presentations may be between 5 to 15 

minutes, depending on the number of 

people who wish to present. Confirmed 

presenters need to send final electronic 

presentations in Microsoft PowerPoint, 

Microsoft Word, or PDF by October 20, 

2006 to CDRHUDI@fda.hhs.gov. 

VI. Transcripts 

The meeting will be transcribed and 

will be available on the Internet at 

www.fda.gov/cdrh/ocd/udi/index.html. 

You may also request a copy of the 

transcript by writing to our Freedom of 

Information Office (HFI–35), Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 12A–16, Rockville, MD 20857. 

We anticipate that transcripts will be 

available approximately 10 days after 

the public meeting at a cost of 10 cents 

per page. The transcripts will also be 

available for public examination at the 

Division of Dockets Management (HFA–

305), 5630 Fishers Lane, rm. 1061, 

Rockville, MD 20852, between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: September 15, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–7969 Filed 9–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, call the 

HRSA Reports Clearance Officer at (301) 

443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: The Stem Cell 

Therapeutic Outcomes Database—

(New) 

The Stem Cell Therapeutic and 

Research Act of 2005 provides for the 

collection and maintenance of human 

blood stem cells for the treatment of 

patients and research. The Health 

Resources and Services 

Administration’s (HRSA), Healthcare 

Systems Bureau (HSB), is establishing 

the Stem Cell Therapeutic Outcomes 

Database. Operation of this database 

necessitates certain record keeping and 

reporting requirements in order to 

perform the functions related to 

hematopoietic stem cell transplantation 

under contract to HHS. The Act requires 

the Secretary to contract for the 

collection and maintenance of 

information related to patients who 

have received stem cell therapeutic 

products and to do so using a 

standardized, electronic format. Data 

will be collected from transplant centers 

in a manner similar to the data 

collection activities conducted by The 

Center for International Blood and 

Marrow Transplant Research (CIBMTR) 

and will be used for ongoing analysis of 

transplant outcomes. HRSA will use the 

information in order to carry out its 

statutory responsibilities. Information is 

needed to monitor the clinical status of 

transplantation, and to provide the 

Secretary with an annual report of 

transplant center-specific survival data. 

The estimate of burden is as follows: 

Record keeping Number of responses 

Responses 

per respondent 

Total responses Hours per response Total burden 

hours 

Baseline Patient/Day of Transplant Data ........................ 250 40 8,000 2 .25 18,000 

Product Receipt/Analysis/Preparation Data ..................... 250 40 8,000 1 8,000 

100-Day Post-Transplant Data ........................................ 250 40 8,000 2 .25 18,000 

6-Month Post Transplant Data ......................................... 250 28 5,538 2 .25 12,460 .5 

12-Month Post-Transplant Data ....................................... 250 22 4,308 2 .25 9,693 

Annual Post-Transplant Data (year two and beyond) ..... 250 40 8,000 2 .25 18,000 

Death Information ............................................................ 250 25 4,923 0 .5 2,461 .5 

Total .......................................................................... 250 ........................ 46,769 .......................... 86,615 


sroberts on PROD1PC70 with NOTICES
55494 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 

Send comments to Susan G. Queen, 

Ph.D., HRSA Reports Clearance Officer, 

Room 10–33, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857. 

Written comments should be received 

within 60 days of this notice. 

Dated: September 15, 2006. 

Cheryl R. Dammons, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. 06–8020 Filed 9–21–06; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Heritable 

Disorders and Genetic Diseases in 

Newborns and Children; Notice of 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Committee on Heritable 

Disorders and Genetic Diseases in Newborns 

and Children (ACHDGDNC). 

Dates and Times: November 2, 2006, 9 a.m. 

to 5 p.m. November 3, 2006, 8:30 a.m. to 3 

p.m. 

Place: Hilton Washington Hotel, 

Georgetown Room, 1919 Connecticut 

Avenue, NW., Washington, DC 20009. 

Status: The meeting will be open to the 

public with attendance limited to space 

availability. 

Purpose: The Committee was established 

specifically to advise and guide the Secretary 

regarding the most appropriate application of 

universal newborn screening tests, 

technologies, policies, guidelines and 

programs for effectively reducing morbidity 

and mortality in newborns and children 

having or at risk for heritable disorders. The 

Committee also provides advice and 

recommendations concerning the grants and 

projects authorized under the Heritable 

Disorders Program and technical information 

to develop policies and priorities for this 

program. The Heritable Disorders Program 

was established to enhance the ability of 

State and local health agencies to provide for 

newborn and child screening, counseling and 

health care services for newborns and 

children having or at risk for heritable 

disorders. 

Agenda: The meeting will include a report 

on the nomination process for newborn 

screening candidate conditions, as well as 

the continued work and reports by the 

Committee’s subcommittees on laboratory 

standards and procedures, follow-up and 

treatment, and education and training. 

Proposed agenda items are subject to 

change. 

Time will be provided each day for public 

comment. Individuals who wish to provide 

public comment or who plan to attend the 

meeting and need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should notify 

the ACHDGDNC Executive Secretary, 

Michele A. Lloyd-Puryear, M.D., Ph.D. 

(contact information provided below). 

For Further Information Contact: Anyone 

interested in obtaining a roster of members or 

other relevant information should write or 

contact Michele A. Lloyd-Puryear, M.D., 

Ph.D., Maternal and Child Health Bureau, 

Health Resources and Services 

Administration, Room 18A–19, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

Maryland 20857, Telephone (301) 443–1080. 

Information on the Advisory Committee is 

available at http://mchb.hrsa.gov/programs/ 

genetics/committee. 

Dated: September 15, 2006. 

Cheryl R. Dammons, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. 06–8018 Filed 9–21–06; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Meeting of the Advisory 

Committee on Organ Transplantation 

AGENCY: Health Resources and Services 

Administration, HHS. 

SUMMARY: Pursuant to Public Law 92–

463, the Federal Advisory Committee 

Act, as amended (5 U.S.C. Appendix 2), 

notice is hereby given of the eleventh 

meeting of the Advisory Committee on 

Organ Transplantation (ACOT), 

Department of Health and Human 

Services (HHS). The meeting will be 

held from approximately 9 a.m. to 5:30 

p.m. on November 2, 2006, and from 9 

a.m. to 3 p.m. on November 3, 2006, at 

the Bethesda DoubleTree Hotel, 8120 

Wisconsin Avenue, Bethesda, MD 

20814. The meeting will be open to the 

public; however, seating is limited and 

pre-registration is encouraged (see 

below). 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, section 222 

of the Public Health Service Act, as 

amended, and 42 CFR 121.12 (2000), 

ACOT was established to assist the 

Secretary in enhancing organ donation, 

ensuring that the system of organ 

transplantation is grounded in the best 

available medical science, and assuring 

the public that the system is as effective 

and equitable as possible, and, thereby, 

increasing public confidence in the 

integrity and effectiveness of the 

transplantation system. ACOT is 

composed of up to 25 members, 

including the Chair. Members are 

serving as Special Government 

Employees and have diverse 

backgrounds in fields such as organ 

donation, health care public policy, 

transplantation medicine and surgery, 

critical care medicine and other medical 

specialties involved in the identification 

and referral of donors, non-physician 

transplant professions, nursing, 

epidemiology, immunology, law and 

bioethics, behavioral sciences, 

economics and statistics, as well as 

representatives of transplant candidates, 

transplant recipients, organ donors, and 

family members. 

ACOT will hear presentations on the 

revised Uniform Anatomical Gift Act; 

the United Network for Organ Sharing 

Department of Evaluation and Quality; 

the Hollywood Health and Society 

Project; new developments in 

immunosuppression; and payment for 

organs. 

The draft meeting agenda will be 

available on October 16 on the 

Department’s donation Web site at 

http://www.organdonor.gov/acot.html. 

A registration form will be available 

on October 2 on the Department’s 

donation Web site at http:// 

www.organdonor.gov/acot.html. The 

completed registration form should be 

submitted by facsimile to Professional 

and Scientific Associates (PSA), the 

logistical support contractor for the 

meeting, at fax number (703) 234–1701. 

Individuals without access to the 

Internet who wish to register may call 

Sowjanya Kotakonda with PSA at (703) 

234–1737. Registration can also be 

completed electronically at http:// 

www.psava.com/dot/acot2006/. 

Individuals who plan to attend the 

meeting and need special assistance, 

such as sign language interpretation or 

other reasonable accommodations, 

should notify the ACOT Executive 

Secretary, Remy Aronoff, in advance of 

the meeting. Mr. Aronoff may be 

reached by telephone at 301–443–3264, 

e-mail: Remy.Aronoff@hrsa.hhs.gov or 

in writing at the address provided 

below. Management and support 

services for ACOT functions are 

provided by the Division of 

Transplantation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration, 5600 Fishers Lane, 

Parklawn Building, Room 12C–06, 

Rockville, Maryland 20857; telephone 

number 301–443–7577. 

After the presentations and ACOT 

discussions, members of the public will 

have an opportunity to provide 

comments. Because of the Committee’s 

full agenda and the timeframe in which 

to cover the agenda topics, public 

comment will be limited. All public 


sroberts on PROD1PC70 with NOTICES